Crafting a new pharmacy benefit manager (PBM) agreement may feel like an uphill battle when you do not have the time and resources to develop a highly customized contract. While it is often more beneficial to a health plan to...more
On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more
Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more
On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
In Advisory Opinion 16-06, the Office of Inspector General (OIG) approved a proposal whereby the ownership of a group purchasing organization (GPO) would be restructured so that the GPO will be wholly owned by the same...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) on May 9, 2016, issued Advisory Opinion 16-06, finding a sufficiently low level of risk in a group purchasing organization (GPO) arrangement...more
On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more
The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health...more
The Centers for Medicare & Medicaid Services (CMS) announced today that it had released an improved Open Payments website. The website has been enhanced with a homepage tool for searching by doctor name, a “snapshot” of Open...more
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more
The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more
The Centers for Medicare & Medicaid Services (CMS) released this week 5 new frequently asked questions (FAQs) related to reporting payments and transfers of value provided by applicable manufacturers and group purchasing...more
Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. The GAO questioned whether the current structure of GPO funding through administrative fees is...more
The GAO had drawn a bead on GPOs. In a report issued yesterday the Government Accountability Office expressed concern over the effect of GPOs (group purchasing organizations) on Medicare rates. The report recommended that...more
During the 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum on November 4, 2014, Douglas Brown, Deputy Director of the Data Sharing & Partnership Group within CMS’s Center for Program Integrity,...more